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Blister standards higher than cap-and-vial, says HCPC

The Consumer Product Safety Commission has proposed a set of mandatory child-resistant packaging requirements for drugs that are switched from prescription to over-the-counter status.

These products would automatically be required to use packaging that passes CPSC’s child-resistant test protocol. The Healthcare Compliance Packaging Council opposes the mandatory requirements unless CPSC changes its protocol to remove the current disincentives to the greater use of blister packs. According to HCPC, unit-dose packaging is held to a higher standard than that of cap-and-vial closures. The organization, which promotes the use of unit- dose blister and strip packaging, also objects to CPSC’s practice of giving small children actual drug packages to open during the tests and telling them they may use their teeth to get them open. HCPC noted that, according to 17 years of CSPC’s poisoning data, blister packaging was cited in only 4% of all incidents in which children six years old and younger swallowed drugs, none of which resulted in death and only two in hospitalizations. Blister packaging that passed CPSC’s child-resistant test protocol was cited in just two cases in that time. By contrast, supposedly child-resistant cap-and-vial closures were cited in almost 64% of poisonings and were involved in 28 deaths and 47 hospitalizations during the 17 years. “While we are troubled by several aspects of the CPSC proposal, our primary concern is that CPSC is putting kids at even greater risk by continuing disincentives to the use of safer packaging that exist under its current test protocol for child-resistant packaging, and expanding these disincentives to more drug products,” said HCPC executive director Peter G. Mayberry.

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